Country: Israel
Language: English
Source: Ministry of Health
FEBANTEL; PRAZIQUANTEL; PYRANTEL
A.L. MEDI-MARKET LTD.
TABLETS
FEBANTEL 150 MG; PYRANTEL 50 MG; PRAZIQUANTEL 50 MG
PER OS
Required
CHANELLE PHARMACEUTICALS MANUFACTURING LTD., IRELAND
In dogs: Treatment of mixed infections by nematodes and cestodes of the following species:Nematodes:Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).Whipworms: Trichuris vulpis (adults).Cestodes: Tapeworms: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
2021-10-31
CONSUMER PACKAGE INSERT FOR A VETERINARY PREPARATION The medicine is dispensed with a veterinarian’s prescription only For animal treatment only 1. NAME OF THE VETERINARY MEDICINE, ITS FORM AND STRENGTH PRAZITEL PLUS VETERINARY TABLETS 2. ACTIVE INGREDIENTS Each tablet contains: Praziquantel 50 mg, pyrantel 50 mg (equivalent to 144 mg pyrantel embonate), Febantel 150 mg. Inactive and allergenic ingredients: see section 13 ”Further information“. 3. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of nematodes and cestodes in dogs, of the following species: NEMATODES: ASCARIDS: Toxocara canis, Toxascaris leonina (adult and late immature forms). HOOKWORMS: Uncinaria stenocephala, Ancylostoma caninum (adults). WHIPWORMS: Trichuris vulpis (adults). CESTODES: TAPEWORMS: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis) Dipylidium caninum (adult and immature forms). THERAPEUTIC GROUP: Anthelmintic. 4. CONTRAINDICATIONS Do not use the product simultaneously with preparations containing piperazine as the anthelmintic activity of pyrantel and piperazine may be contraindicated. Do not use the product in animals with a known sensitivity to the active ingredients or to any of the inactive ingredients. 5. SIDE EFFECTS In very rare cases, gastrointestinal disturbances (diarrhea, vomiting) have been observed. If you notice any serious adverse reactions not mentioned in this leaflet, please inform your veterinarian. Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects of Drug Treatment“ found on the Ministry of Health homepage (www.health.gov.il), that directs you to the online form for reporting side effects, or by entering the link: http://sideeffects.health.gov.il 6. TARGET SPECIES Dogs 7. MODE OF ADMINISTRATION AND DOSAGE SINGLE DOSE: FOR ORAL ADMINISTRATION. The recommended dosage are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to approximately 14.4 mg/kg pyrantel embonate) and 5 Read the complete document
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prazitel Plus Veterinary Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: Praziquantel 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) 50 mg Febantel 150 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet A pale yellow tablet with a cross breakline on one side. The tablets can be divided into 2 or 4 equal parts 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: Treatment of mixed infections by nematodes and cestodes of the following species NEMATODES: ASCARIDS: _Toxocara canis_, _Toxascaris leonina_ (adult and late immature forms). HOOKWORMS: _Uncinaria stenocephala_, _Ancylostoma caninum_ (adults). WHIPWORMS: _Trichuris vulpis_ (adults). CESTODES: TAPEWORMS: _Echinococcus_ species, _(E. granulosus, E. multilocularis), Taenia_ species, _(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum_ (adult and immature forms). 4.3 CONTRAINDICATIONS Page 2 of 6 Do not use simultaneously with piperazine compounds. Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Fleas serve as intermediate hosts for one common type of tapeworm – _Dipylidium _ _caninum_. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken. Tapeworm infestation is unlikely in pups less than 6 weeks of age. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidental ingestion, seek medical advice and show the package leaflet to the physician. In the interests of Read the complete document